Z-1280-2015Class II

Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra...

Name: Z-1280-2015 Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2015-01-23
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2015-01-23 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a... on 2015-01-23. FDA classified it as Class II and gives the reason as "An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1280-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Posted: 2015-03-16
Terminated: 2017-04-20
Recalling firm: Datascope Corp.
Product: Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Mindray DS USA Inc sent Urgent: Passport V Monitor Field Corrective Action letters dated 1/23/2015 to hospital administrators. The letters informed customers that the IBP module may provide an incorrect IBP measurement. The letter also explained the adverse effects on patients. Customers are asked to either calibrate the IBP following the instructions provided; or, contact a Mindray Service Representative, who can perform the calibration, at 1-800-288-2121. In the case of the second option, it is recommended that the monitor be removed from service until the calibration is performed. If the first option is chosen, customers are to notify a Service Representative upon completion of the action. Customers can direct their questions to Diane Arpino at 201-995-8407.
Quantity in commerce: 519 units
Distribution: Nationwide Distribution
Product codes and lots: 6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1280-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1280-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-16

Product code MHX

K091834Class IIPassport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division / cleared 2009-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)